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Brexpiprazole (Rexulti) Clinical Policy: Brexpiprazole (Rexulti) Reference Number: AZ.CP.PMN.68 Effective Date: 04.25.16 Last Review Date: 08.20 Line of Business: Arizona Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Brexpiprazole (Rexulti®) is an atypical antipsychotic. FDA Approved Indication(s) Rexulti is indicated for the: • Adjunctive treatment of major depressive disorder (MDD) • Treatment of schizophrenia. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of Arizona Complete Health that Rexulti is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Major Depressive Disorder (must meet all): 1. Diagnosis of MDD; 2. Age ≥ 18 years; 3. Failure of THREE preferred antidepressants (e.g., selective serotonin reuptake inhibitor [SSRI], serotonin-norepinephrine reuptake inhibitor [SNRI], tricyclic antidepressant [TCA], bupropion, mirtazapine) from at least TWO different classes at up to maximally indicated doses, each used for ≥ 4 weeks, unless contraindicated or clinically significant adverse effects are experienced; 4. Failure of a ≥ 4-week trial of aripiprazole at up to maximally indicated doses, used concurrently with an antidepressant, unless contraindicated or clinically significant adverse effects are experienced; 5. Rexulti is prescribed concurrently with an antidepressant; 6. Dose does not exceed 3 mg (1 tablet) per day. Approval duration: 12 months B. Schizophrenia Spectrum Disorder (must meet all): 1. Diagnosis of schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder, schizophreniform disorders); 2. Age ≥ 18 years; 3. Failure of THREE preferred atypical antipsychotics, one of which must be aripiprazole at up to maximally indicated doses, each used for ≥ 4 weeks, unless contraindicated or clinically significant adverse effects are experienced; Page 1 of 7 CLINICAL POLICY Brexpiprazole 4. Dose does not exceed 4 mg (1 tablet) per day. Approval duration: 12 months C. Other diagnoses/indications 1. Refer to the off-label use policy for the relevant line of business if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized): AZ.CP.PMN.53 for Arizona Medicaid. II. Continued Therapy A. All Indications in Section I (must meet all): 1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Documentation supports that member is currently receiving Rexulti for schizophrenia and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed (a or b): a. MDD: 3 mg (1 tablet) per day; b. Schizophrenia: 4 mg (1 tablet) per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via Centene benefit and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to the off-label use policy for the relevant line of business if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized): AZ.CP.PMN.53 for Arizona Medicaid. III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – AZ.CP.PMN.53 for Arizona Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BMI: body mass index SNRI: serotonin-norepinephrine CrCl: creatinine clearance reuptake inhibitors CYP: cytochrome P450 SSRI: selective serotonin reuptake FDA: Food and Drug Administration inhibitors MDD: major depressive disorder TCA: tricyclic antidepressants Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. Page 2 of 7 CLINICAL POLICY Brexpiprazole Drug Name Dosing Regimen Dose Limit/ Maximum Dose Antipsychotics aripiprazole (Abilify) Schizophrenia Schizophrenia: 30 Adults: 10 to 15 mg PO QD mg/day Major Depressive Disorder Major Depressive 5 to 10 mg PO QD Disorder: 15 mg/day clozapine Schizophrenia Schizophrenia:900 Initial: 12.5 mg PO BID; target: 300 to mg/day 450 mg/day Lurasidone (Latuda®) Schizophrenia Schizophrenia: 160 Adults: 40 mg PO QD with food (at mg once daily. least 350 Calories). olanzapine (Zyprexa®) Schizophrenia 20 mg/day Initial: 5 to 10 mg PO QD; target: 10 mg PO QD quetiapine Schizophrenia 800 mg/day immediate-release Initial: 25 mg PO BID; target: 400 to (Seroquel®) 800 mg/day risperidone (Risperdal®) Schizophrenia Schizophrenia Initial: 1 mg PO BID or 2 mg PO QD; Adolescents: 6 target: 4 to 8 mg PO QD mg/day Adults: 16 mg/day ziprasidone (Geodon®) Schizophrenia 160 mg/day 20 mg PO BID Selective Serotonin Reuptake Inhibitors (SSRIs) citalopram (Celexa®) 40 mg/day escitalopram (Lexapro®) 20 mg/day fluoxetine (Prozac®) Immediate-release: 80 mg/day (20 mg/day if pediatric) Delayed-release: 90 mg/week fluvoxamine* 150 mg/day (immediate-release) Major Depressive Disorder (Luvox®) Major Depressive Disorder Refer to prescribing information paroxetine (Paxil®, Paxil Immediate-release: CR®, Pexeva®) 50 mg/day (40 mg/day if geriatric) Extended-release: 62.5 mg/day (50 mg/day if geriatric) sertraline (Zoloft®) 200 mg/day (20 mg/day if age 6-11 years*) Page 3 of 7 CLINICAL POLICY Brexpiprazole Drug Name Dosing Regimen Dose Limit/ Maximum Dose Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) duloxetine (Cymbalta®) 120 mg/day Major Depressive Disorder venlafaxine (Effexor®, Extended-release: Refer to prescribing information Effexor XR®) 225 mg/day Tricyclic Antidepressant (TCAs) amitriptyline (Elavil®) 150 mg/day amoxapine 400 mg/day (300 mg/day if geriatric) clomipramine* 250 mg/day (200 (Anafranil®) mg/day if pediatric) desipramine 300 mg/day (100 (Norpramin®) mg/day if pediatric) doxepin (Sinequan®) 300 mg/day imipramine HCl 200 mg/day (150 (Tofranil®) mg/day if geriatric MajorMajor DepressiveDepressive DisorderDisorder or pediatric) ReferRefer toto prescribingprescribing informationinformation imipramine pamoate 200 mg/day (100 ® (Tofranil PM ) mg/day if geriatric or pediatric) ® nortriptyline (Pamelor ) 150 mg/day ® protriptyline (Vivactil ) 60 mg/day (30 mg/day if geriatric or pediatric) trimipramine 200 mg/day (100 ® (Surmontil ) mg/day if geriatric or pediatric) Monoamine Oxidase Inhibitors ® selegiline (EMSAM Transdermal: 12 ® Major Depressive Disorder transdermal; Eldepryl , mg/24 hr Refer to prescribing information Zelapar®, Carbex®) Oral*: 30 mg/day Other Antidepressants bupropion (Aplenzin®, Immediate-release: Budeprion SR® , 450 mg/day (300 Budeprion XL®, Forfivo mg/day if pediatric) XL®, Wellbutrin®, Sustained-release: Wellbutrin SR®, 400 mg/day Wellbutrin XL®) Major Depressive Disorder Extended-release Refer to prescribing information (HCl): 450 mg/day Extended-release (HBr): 522 mg/day mirtazapine (Remeron®) 45 mg/day maprotiline (Ludiomil®) 150 mg/day trazodone (Desyrel®, Immediate-release: Page 4 of 7 CLINICAL POLICY Brexpiprazole Drug Name Dosing Regimen Dose Limit/ Maximum Dose ® Oleptro ) 400 mg/day Extended-release: 375 mg/day Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): known hypersensitivity to Rexulti or any of its components • Boxed warning(s): o Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. Rexulti is not approved for the treatment of patients with dementia-related psychosis. o Antidepressants increase the risk of suicidal thoughts and behaviors in patients aged 24 years and younger. Monitor for clinical worsening and emergence of suicidal thoughts and behaviors. o Safety and effectiveness of Rexulti have not been established in pediatric patients. Appendix D: General Information • Schizophrenia Spectrum and other psychotic disorders include schizophrenia, and other psychotic disorders and schizotypal (personality) disorder. They are defined by abnormalities in one or more of the following 5 domains: Delusions, hallucinations, disorganized thinking, grossly disorganized or abnormal motor behavior including catatonia, and negative symptoms. V. Dosage and Administration Indication Dosing Regimen Maximum Dose Adjunctive treatment 0.5 mg or 1 mg PO QD, up to the target 3 mg/day of MDD dosage of 2 mg once daily Schizophrenia 1 mg PO QD, up to target dosage of 2 4 mg/day mg to 4 mg once daily • Moderate to severe hepatic impairment (Child-Pugh score ≥ 7): Maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia • Moderate, severe or end-stage renal impairment [creatinine clearance (CrCl) < 60 mL/minute): Maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia • Known cytochrome P450 (CYP)
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